Treatment-Resistant Depression in a Real-World Setting: First Interim Analysis of Characteristics, Healthcare Resource Use, and Utility Values of the FondaMental Cohort

Abstract

Background: Major depressive disorder (MDD) is among the most common psychiatric disorders. One-third of patients are usually unresponsive to several lines of treatment. This study aimed to describe the FondaMental French cohort of patients with treatment-resistant depression (TRD) and to estimate utility and healthcare resource use outcomes. Methods: Patients with TRD were evaluated prospectively over four years (baseline, 6, 12, 18, 24, 36 and 48 months) in a real-world clinical setting. Interim analyses focused on the first two consecutive years. Four MDD-related states (major depressive episode (MDE), response, remission, recovery) were defined based on the MADRS (Montgomery–Åsberg depression rating scale) and other clinical events. Health status was assessed with the EuroQol 5 Dimensions 5 Level (EQ-5D-5L) questionnaire. Utility values were estimated as preference measures that the patients assigned to their overall health status. Results: This study was based on 252 patients with TRD. The mean utility value by health state was 0.41, 0.63, 0.80, and 0.90, for MDE, response, remission, and recovery, respectively. At baseline, 59% of patients had an MADRS score of at least 28. Their baseline average utility value was lower compared to the other patients (0.43 versus 0.58, p < 0.001). This significant difference persisted at the following visits. The rate of patients in MDEs having at least one hospitalisation for depression or other reasons than depression was generally higher than that in the other health states. Conclusion: This study documented patterns in healthcare resource consumption, quality of life, and other characteristics in patients with TRD, both globally and by health state and depression severity.

Clinical Features and Outcomes of 124 Italian Patients With Treatment Resistant Depression: A Real-World, Prospective Study

“…Confirming the high burden of TRD, our patients showed low quality of life and poor functioning, together with a substantial degree of disability. In particular, we observed a mean utility value derived from EQ-5D-5L of 0.44, similar to that reported in a recently published French TRD cohort (26). The much lower employment rate in our study (34%, which increased to 39% when calculated excluding retired patients) compared to that reported for the Italian population (63% among individuals aged 20-64 years in 2018 according to the Italian National Institute of Statistics) is not unexpected and confirms the personal and social burden of TRD.…”

“…Real-world evidence on patients with TRD is scarce (15,24,25), especially from European countries (26), and mainly derived from retrospective studies based on administrative databases or electronic health records (27)(28)(29). Within these studies, data on prescribing patterns and illness outcome are sparsely reported (24)(25)(26)30).…”

“…Real-world evidence on patients with TRD is scarce (15,24,25), especially from European countries (26), and mainly derived from retrospective studies based on administrative databases or electronic health records (27)(28)(29). Within these studies, data on prescribing patterns and illness outcome are sparsely reported (24)(25)(26)30). Real-world data are of paramount importance since patients included in randomized clinical trials (RCTs) of depression are poorly representative of the treatment-seeking depressive patients in routinary clinical practice.…”

The Impact of Underlying Conditions on Quality-of-Life Measurement Among Patients with Chronic Wounds, as Measured by Utility Values: A Review with an Additional Study

“…For MAUIs, such as the EQ-5D-5L, derivation of utility values using the mapping process is a reflection, in part, of the country-specific culture and how individuals value different health-related issues. 3 Methods designed to directly elicit utility values for aspects of single diseases suffer from several analogous limitations, as well as methodological issues, particularly for certain comorbidities whose impact varies, such as the diurnal pattern of rheumatoid arthritis, 101 episodes of depression, 102 or of a limited duration, such as surgical wounds. 9 Consequently, while these values are certainly very useful, the methodology underpinning their estimation should still be judged as a “work in progress,” despite a positive future outlook.…”

Treatment-Resistant Depression in Poland—Epidemiology and Treatment

“…Despite the existence of validated measures of depressive symptom severity, Rizvi reported that only 25% of doctors in their study used them. While some studies on TRD use standardized scales to assess improvement [28,31,62], others use doctors' evaluations [29] or data regarding treatment found in administrative databases [23,31,32,63]. Our project was based on real-world evidence, and its aim was to reflect decisions made by psychiatrists in practice.…”